FDA WARNING_LETTER - CATSMO LLC - December 12, 2019

The FDA inspected Catsmo LLC's RTE seafood processing facility from November 18 to December 12, 2019. The inspection revealed serious violations of the seafood HACCP regulation (21 CFR 123) and the presence of *Listeria monocytogenes* (L. mono). Environmental swabs confirmed L. mono, with three of five positive swabs from food-contact surfaces (scissors/cutting board, conveyor belt, slicer). Whole genome sequencing showed a single strain genetically identical to isolates from another facility and a clinical isolate. This indicates inadequate control of L. mono.

Violations included insufficient monitoring of CGMPs (21 CFR 117, Subpart B). Specifically, equipment was not adequately cleaned (gouged cutting board, worn plastic trays with residue), and effective measures were not taken to protect food from contamination (cleaning operations near exposed RTE salmon, high-pressure hose used for cleaning and then touching utensils, with L. mono found on the hose nozzle). Condensation was observed dripping onto RTE salmon fillets, a repeat observation.

Catsmo LLC's response included a voluntary recall, temporary cessation of operations, equipment replacement, cleaning, and hiring consultants. However, documentation for updated procedures was not provided. The FDA also noted a deviation from a critical limit for water phase salt in cold smoked salmon, which the firm attributed to R&D. Failure to correct violations may lead to regulatory action and re-inspection fees.